Maxillofacial and craniofacial injuries encompass any injury to the mouth, face and jaw. Common serious injury to the face occurs when bones are broken (a fracture). Fractures can involve the lower jaw, upper jaw, palate, cheekbones, eye sockets and combinations of these bones. The fracture needs to be held in the correct position while the bone is healing. In most cases this requires fixing the bones using metal or biodegradable plates and screws, known as internal fixation.
There are a variety of micro, mini and reconstruction plating systems. One of the most commonly used plating system developed to date is the Luhr system manufactured by Howmedica, Inc. Subsequently, based on the original concept by Luhr, several complete systems have been developed for use in all the various situations encountered in trauma and reconstructive surgery of the facial skeleton. Techniques and materials used for the internal fixation of the maxillofacial skeleton continue to evolve and improve. For example, metal plates have been used for the repair of craniomaxillofacial bone fractures. These metal plates are generally secured to the fractured bone portions with fasteners such as screws. The plates conventionally employed generally comprise small, generally flat, elongated sections of metal. The sections contain round screw holes at various points along their lengths for fastening the sections to bone. The metal plate is then bent into shape and secured to the fractured bone using a plurality of fasteners seated within the screw holes. While known systems utilizing plates and fasteners for aiding the osteosynthesis of severed bone regions have proven to be acceptable for certain applications, such systems are nevertheless susceptible to improvements that may enhance their performance. For example, metals are difficult to shape and are hampered by disadvantages such as infection and corrosion. Several resorbable plate and screw fixation systems are now available for use in the maxillofacial skeleton. These systems allow initial stable fixation of bone segments during the bone-healing phase and then gradually are reabsorbed through physiologic processes.
Regardless of the plate system used, the plate must be contoured to lay passively against the underlying bone surfaces. Therefore, even though the plating systems themselves are manufactured with extremely precise tolerances, an element of imprecision remains for surgeons who repair facial fractures and do orthognathic surgery or reconstructive procedures repositioning the facial skeletal structures to improve esthetics or function. When an osteotomy, fracture, or bone graft is placed into appropriate position, the bone plate has to be manually bent to the contour of the anatomy. This manual manipulation creates a substantial element of imprecision even with the use of templates. Maladapted bone plates lead to inappropriate bone contour, irritation of the overlying soft tissues, abnormal anatomy or contour defects and either non-union, malunion or unaesthetic results.
Thus, there is a need in the art for devices and methods for repairing maxillofacial and craniofacial bony defects that are easy to use, biocompatible, require minimal manipulation once in place, and are customizable on a patient-by-patient basis.